RAJGOPAL GLASS PPT (Q.C test with it's limit)

50 %
50 %
Information about RAJGOPAL GLASS PPT (Q.C test with it's limit)

Published on March 8, 2014

Author: razja

Source: authorstream.com

PowerPoint Presentation: PACKAGING MATERIAL RAJGOPAL M.PHARM PHARMACEUTICS MATERIALS USED FOR PHARMACEUTICAL CONTAINERS 1 PowerPoint Presentation:  PROPERTIES OF GOOD CONTAINER (1). Neutral , Compatible. (2). No Physical /Chemical Interaction with the Substance/Dosage Form it Holds. (3). Protection of Dosage Form From External Environment. (4). Non Toxic . (5). Easy Labeling. (6). Elegant Appearance . (7). Withstand Changes in Temp and Pressure. (8). Easy Withdrawal of Dose. 2 2 PowerPoint Presentation:  MATERIALS USED FOR MAKING CONTAINERS (1). GLASS . (3). METALS. (2). PLASTIC . (4). PAPER & BOARD. GLASS Primary Packaging Material , Container of Choice , Specially for Small volume Parenteral Preparation . QUALITY OF GLASS AS CONTAINER (1). Cleanliness . (4). Impermeability to (2). Transparency . Liquids & Pyrogens . (3). Light Protection . (5). Resistance To High Temp erature 3 3 WHAT IS GLASS?: WHAT IS GLASS ? (1 ) An Amorphous Inorganic Product of Fusion That has been Cooled to Rigid Condition Without Crystallizing. It’s Not a Crystalline Solid, not a Liquid. It is a Frozen Liquid . (2) Pharmaceutical Containers can be Defined as Device which Holds the Drug Product / Dosage Form and May be or May Not be in Direct Contact with the Dosage Form. 4 PowerPoint Presentation:  TYPES OF CONTAINER ON BASIS OF UTILITY AND METHOD OF CLOSURES (1) Well Closed Container . (2) Single Dose Container (3) Multi -dose Container. (4) Light Resistant Container. (5) Air Tight Container. (6) Aerosol Container. (7) Hermitically Sealed Container. Ex- Glass Ampoule. 5 General Chemical Composition: General Chemical Composition Component Percentage (approx) Silica (SiO 2 ) 72 % Lime (CaCO 3 ) 11 % Soda (NaCO 3 ) 14 % Alumina (Al 2 O 3 ) 1.75 % Potash 0.3 % 6 PowerPoint Presentation: COMPOSITION OF GLASS (1) . PRINCIPALLY SILICON DI OXIDE , SAND , SILICA, LIME STONE, ALUMINA , POTASH (2) . ALKALI METAL OXIDE  ex. Sodium Oxide. (3) . ALKALI EARTH OXIDE  ex. CALCIUM OXIDE . (4) . TRACE ELEMENT  OXIDE OF POTTASIUM , IRON , ALUMINIUM , MAGNESIUM , ZINC , BORON , BARIUM . (5) . CULLETS :-- Broken, Crushed, Powdered, Glass used as Fusion Agent . 7 PowerPoint Presentation: 8 (1) Glass Structurally Consist of Tetrahedron Silicon Di oxide . (2) Moulding Occurs at High Temp. But it is Brittle and Hard. (3) Addition of Boric Oxide Modifies the Brittleness of Glass. (4) But other Oxides particularly Sodium & Calcium enters the Structural unit of Glass & Reduces Inter-Molecular Force of Attraction Between Silicon & Oxygen Reduces M.p of Glass, But They are Free to Migrate & can Leach in the Solution . This Process is Leaching of Alkali 8 GLASS BRITTLENESS MODIFIER PowerPoint Presentation:  TYPES OF GLASS ( USP ) (on basis of amount of alkali oxide leaching in solution and hydrolytic resistance of glass.) (1) SODA LIME GLASS Silicon Di Oxide - -(75%) Sodium Oxide--- (15%) Calcium Oxide--- (10%) Trace Elements----Magnesium Oxide, Potassium Oxide, Aluminum Oxide DEMERITS (a) Liberates Alkali (b) Flaking (c) Low Hydrolytic Resistance USE : - Non-Aqueous /Powder for Parenteral use. . 9 PowerPoint Presentation:  ( 2) SODA LIME GLASS ( Surface Treated Glass ) (Inner Surface of Glass is Treated with Silicon Di Oxide.) MERITS  High Hydrolytic Resistance . US E  Suitable for Aqueous (Acidic or Neutral) Preparation Whether or Not for Parenteral use . (3) SULPHURATED GLASS Inner Surface of Soda Lime Glass is Exposed to Sulphur Di Oxide Gas at 500 Degree Temp to Produce Sulphurated Glass . MERITS  Moderate Hydrolytic Resistance 10 PowerPoint Presentation: BOROSILICATE / NEUTRAL GLASS Silicon Di- Oxide --80% Boric Oxide -----12% Aluminum Oxide--6% Trace Elements:----2% (Sodium Oxide, Calcium Oxide & Other Oxides) MERITS  (1) High Hydrolytic Resistance (2) No Alkali Leaching . USE  Most of Product Whether or Not For Parenteral use INNER SURFACE OF GLASS IS SUBJECTED TO PLASMA IMPULSE CHEMICAL VAPOUR DEPOSITION TECHNOLOGY ( PICVD ) AND ON INNER SURFACE ULTRA THIN LAYER OF SILICON DI OXIDE IS APPLIED 11 PowerPoint Presentation: 12 TYPE 1 GLASS NEUTRAL/ BOROSILICATE GLASS Very high Hydrolytic Resistance First Choice as a Container for any Type of Product Whether or Not for Parenteral use TYPE 2 GLASS SODA LIME GLASS ( surface treated ) High Hydrolytic Resistance Suitable for Aqueous (Acidic / Neutral) Preparation Whether or Not for Parent eral Use TYPE 3 GLASS Soda Lime Glass Moderate Hydrolytic Resistance Suitable for Non Aqueous / Powder Preparation Whether or Not for Parenteral U se. TYPE 4 GLASS Soda Lime Glass ( liberating alkali ) Not Suitable for Parenteral Products 12 Glass container Manufacturing Steps: Glass container Manufacturing Steps (2).Melting (3).Forming (4).Annealing (5).Inspection (6).Packaging (1).Batching 13 PowerPoint Presentation:  BATCHING All the Ingredients Mixed Together, and Put into Shuttle Device to Bring the Raw Material to the Furnace. 14 MELTING: MELTING (1) Melting of the ingredients occurs in the furnace, which turns the contents into molten glass. (2) Melting temperature 1550-1600°C 15 FORMING / MOULDING : FORMING / MOULDING Two common processes are used Blow & Blow process Press & Blow process: 16 BLOW AND BLOW PROCESS: BLOW AND BLOW PROCESS 17 PRESS & BLOW PROCESS: PRESS & BLOW PROCESS 18 ANNEALING PROCESS: ANNEALING PROCESS (1) Slow cooling of the glass in order to strengthen the container . (2) A nnealing Point  The specific Temp at which internal stresses build up during glass container formation . Annealing (oven) 540 deg C Holding for 15 minutes Cooling 19 INSPECTION:  INSPECTION Inspection is Carried Out Either Manual or Automatic. 20 POPULAR CONTAINERS: POPULAR CONTAINERS Tubular glass containers Ampoules Vials Disposable syringes 21 AMPOULES : AMPOULES (1) Ampoule is one of the first unit dose container. (2) Scored point, Ceramic point, Colored ring above and below Scored point is Breaking point . 22 VIALS :  VIALS (1) These were popular in 1920s & 1930s . (2) Injection vials are obtained in either Neutral , or Borosilicate Glasses & occasionally in Surface Treated Soda Lime Glasses 23 DISPOSABLE SYRINGES : DISPOSABLE SYRINGES (1) Sterilized glass tube with an end cap seal & movable Plunger is used for unit dose Injectables. (2) These are available with two compartments which allow unstable parts of pharmaceutical Formulation to be kept separate and mix Immediately prior to use. 24 POSSIBLE GLASS CONTAINER DEFECT: POSSIBLE GLASS CONTAINER DEFECT 25 PowerPoint Presentation:  (1) WATER ATTACK TEST (Test for alkali oxide leaching in aqueous soln from type 2 glass) (2) POWDERED GLASS TEST (Test for alkali oxide leaching in aqueous soln from type 1,2 & 3 glass) (3) HYDROLYTIC RESISTANCE TEST ( Test for resistance of glass towards the aqueous soln filled in it ) (4) ARSENIC TEST ( For ampoules & vials) (5) ETCHING TEST (6) THERMAL SHOCK TEST ( Test for breakage / cracking of glass when subjected to frequent heating and cooling) TEST FOR PHARMACEUTICAL GLASS CONTAINER 26 PowerPoint Presentation:  POWDERED GLASS TEST (1) PREPARATION OF GLASS SPECIMEN  FEW GLASS BOTTLES  WASHED ,RINSED WITH WATER- DRIED & CRUSHED  GRINDED  FINE POWDER  PASS THROUGH SIEVE Number 20 / 40  SAMPLE GLASS POWDER . (2) WASHING THE POWDERED GLASS SPECIMEN  10gm POWDERED SAMPLE + 30 ml ACETONE  DECANT  AGAIN WASH WITH 30ml ACETONE  AGAIN DECANT  WASHED POWDERED GLASS SAMPLE DRIED & COLLECTED ( use within 48 hrs for final test) TESTING PROCEDURE : 10 gm WASHED GLASS POWDER SAMPLE + 50 ml PURIFIED WATER  SUBJECT TO AUTOCLAVE AT 121 DEG.CG TEMP FOR 30 mnt  COOL   DECANT AND COLLECT SOLN IN Flask  AGAIN WASH POWDERED SAMPLE WITH 15 ml WATER  AGAIN DECANT THE SOLN IN ABOVE FLASK  FINALLLY TITRATE THE SOLN WITH 0.02 N H2SO4 USING METHYL RED AS INDICATOR . VOLUME OF 0.02 N H2SO4 CONSUMED IS EQUAL TO AMOUNT OF ALKALI OXIDE LEACHED IN AQUEOUS SOLUTION This test is performed to estimate the amount of alkali leaching from Inner surface of glass to aqueous solution filled in glass container. This test is carried out for type 1, type 2 & type 3 glass containers. 27 PowerPoint Presentation:  TYPE NAME SIZE LIMITS T YPE 1 GLASS Highly R esistant B orosilicate Glass ALL 1.0 ml of 0.020 N H2SO4 Sulphuric Acid TYPE 2 GLASS Soda-Lime Glass. ALL 8.5 ml of 0.02N H2SO4 Sulphuric Acid T YPE 3 GLASS Soda-Lime Glass ALL 15.0 ml of 0.020 H2SO4 ( Sulphuric Acid) THIS TEST IS PERFORMED FOR TYPE 1, TYPE 2 & TYPE 3 GLASS. VOLUME OF H2SO4 CONSUMED IS EQUUIVALENT TO ALKALI OXIDE LEACHED FROM GLASS. LIMITS FOR POWDERED GLASS TEST 28 PowerPoint Presentation:  WATER ATTACK TEST THIS TEST IS FOR TYPE 2 GLASS i.e. SODA LIME GLASS INNER SURFACE TREATED WITH SIO2 TO ESTIMATE THE AMOUNT OF ALKALI OXIDE LEACHING IN AQUEOUS SOLN FROM GLASS . PROCEDURE Few Glass Bottles  Wash , Dry  Fill Bottles up to 90 % of its Overflow Volume or up to Brim  Autoclave , 121deg. C Temp. for 30mnts  Cool & Decant Autoclaved Water in Flask  Titrate with 0.02N H2SO4 Using Methyl Red as Indicator . VOLUME OF H2SO4 CONSUMED IS EQUAL TO AMOUNT OF ALKALI OXIDE LEACHED IN AQUEOUS SOLUTION FILLED IN GLASS CONTAINER . 29 PowerPoint Presentation: 30 TYPE NAME LIMITS SIZE VOLUME of 0.02N H2SO4 SULFURIC ACID TYPE 2 GLASS SURFACE TREEATED SODA –LIME GLASS 100 ml OR LESS 0.7 ml Over 100 ml 0.2 ml LIMIT FOR WATER ATTACK TEST/ VOLUME OF H2SO4 CONSUMED IS EQUIVALENT TO AMOUNT OF ALKALI OXIDE LEACHED . 30 PowerPoint Presentation: HYDROLYTIC RESISTANCE TEST THE RESISTANCE OFFERED BY THE INNER SURFACE OF GLASS AGAINST THE ATTACK OF AQUEOUS SOLUTION FILLED . PROCEDURE :- REQUIRED NUMBER OF CONTAINERS, WASHED & DRIED  FILL UP CONTAINERS UP TO 90 % OF ITS OVERFLOW VOLUME OR UP TO BRIM  AUTOCLAVE , (STEAMING) AT 100 deg.cg Temp for 10 mnts   RISE TEMP GRADUALLY FROM 100 to 121 deg.c for 20 minutes  MAINTAIN TEMP OF 121 deg. Cg FOR 60 mnts  FINALLY TEMP is DECREASED FROM 121 DEG. to 100 DEG.CG FOR 40 MINUTES . REMOVE CONTAINERS FROM AUTOCLAVE  COOL  COMBINE ALL AUTOCLAVED AQUEOUS SOLN FROM CONTAINERS IN VOL. FLASK  TITRATE WITH 0.01 N HCL USING METHYL RED AS INDICATOR NOTE THE END POINT READING . NOW PERFORM BLANK TEST WITH WATER & NOTE READING. DIFFERENCE BETWEEN TWO READINGS GIVES AMOUNT OF HCL CONSUMED WHICH IS EQUAVALENT TO ALKALI OXIDE LEACHED IN THE AQUEOUS SOLUTION. 31 PowerPoint Presentation:  Volume of HCL Consumed is Equivalent to Amt of Alkali Oxide Leached Volume of 0.01 M HCl per 100 ml of Test Liquid Filling Volume (ml) Types I and II Type III Up to 1 2.0 20.0 Above 1 and Up to 2 1.8 17.6 Above 2 and Up to 5 1.3 13.2 Above 5 and Up to 10 1.0 10.2 Above 10 and Up to 20 0.80 8.1 Above 20 and Up to 50 0.60 6.1 Above 50 and Up to 100 0.50 4.8 Above 100 and Up to 200 0.40 3.8 Above 200 and Up to 500 0.30 2.9 Above 500 0.20 2.2 LIMITS FOR SURFACE GLASS TEST / HYDROLYTIC RESISTANCE TEST 32 PowerPoint Presentation:  ARSENIC TEST THIS TEST IS USUALLY PERFORMED FOR GLASS CONTAINERS FOR AQUEOUS PARENTRAL PREPARATIONS LIKE AMPOULES & VIALS. THE AIM OF THIS TEST IS TO DETECT THE PRESENCE OF ARSENIC OXIDE IN GLASS CONTAINER. ARSENIC IS CUMALATIVE POISON, SO ITS PRESENCE IS DETECTED IN AQUEOUS INJECTION SOLUTION FILLED IN GLASS CONTAINER PROCEDURE :- 50 AMPOULES 1 ml Capacity  Washed, Dried  Fill 1ml Water & Seal   Autoclave, (Steaming) at 100 deg.cg Temp for 10 mnts  Rise Temp from 100 to 121 deg for 20 mnts  Maintain Temp of 121 deg for 60 mnts  Finally Decrease Temp from 121 deg. to 100 deg. cg for 40 mnts Remove Ampoules From Autoclave  Cool  Mix all Contents of Ampoule , i.e. 50 ml Autoclaved Aqueous Soln . Pipette 10 ml of Above Aqueous Soln  Add 10 ml HNO3 Soln  Dry & Evaporate to Dryness on Water Bath  Dry residue (130 deg.cg, 30 mnts)  Cool  Add 10 ml Hydrogen Molybdate Soln  Swirl to Dissolve  Dry Residue  Heat on Water Bath  Reflux (25 mnts)  Cool  Determine the Absorbance at 840 nm  Perform Blank Test with H2 Molybdate Soln. The Absorbance of the Test Solution should Not be more than the Absorbance Obtained by Repeating the Determination for 0.1 ml of Arsenic Std Soln (10ppm) in place of Test Solution . 33 THANK YOU: THANK YOU 34 DIN 52339–1 (1967) :  Testing of glass; autoclave method for testing the hydrolytic resistance of the interior surfaces of glass containers and determination by titration. ISO 4802 (1998). DIN 52339-2 (1988) :  Testing of glass; autoclave method for testing the hydrolytic resistance of the interior surfaces of glass containers and classification, determination by flame spectrophotometry. British. Pharmacopoea. 1958 Appendix XX Page 963. REFERENCE

Add a comment

Related presentations

Related pages

EXPERIMENT 7 ATTERBERG LIMITS - University of Illinois at ...

EXPERIMENT 7 ATTERBERG LIMITS ... Standard Test Method for Liquid Limit, ... The thread shall be deformed so that its diameter reaches 3.2 mm ...
Read more

Parenteral Products: Pharmacopeial Control of Containers ...

Parenteral Products: Pharmacopeial Control of Containers, ... The limits for tests on the hydrolytic ... The EP also uses the surface glass test to ...
Read more

Microbiological Pharmaceutical Quality Control Labs (7/93)

GUIDE TO INSPECTIONS OF MICROBIOLOGICAL PHARMACEUTICAL QUALITY CONTROL ... who is familiar with the tests being inspected ... definitive microbial limits.
Read more


FACILITIES INSTRUCTIONS, STANDARDS, AND TECHNIQUES ... Oil and/or gas Power factor test. leaks. ... (power factor) limits for bushings Manufacturer Bushing ...
Read more

Basic Lessons in Laboratory Quality Control

4 Basic Lessons in Laboratory Quality Control ... statistical limits ... whether the precision of a specific test is acceptable is to compare its ...
Read more

Test Tubes Powerpoint - Free PowerPoint Templates ...

... Powerpoint Templates » Topic » Medicine / Health » Test Tubes Powerpoint ... Glass Test Tubes PPT is a PowerPoint design for Lab or Chemistry ...
Read more

The Mechanical Properties of Glass

The Mechanical Properties of Glass ... • Drawing fibers from synthetic glass reduces the surface area under test and increases strength ... MechProp.ppt ...
Read more

PPD skin test: MedlinePlus Medical Encyclopedia

PPD skin test. The PPD skin test is a method used to diagnose silent (latent) tuberculosis (TB) infection. PPD stands for purified ...
Read more